Study on AI-Based Drug Dosing for Liver Cancer Treatment

Sponsor: University of Florida

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05669339

Provider View

This clinical trial is testing a new approach using artificial intelligence to determine the best drug doses for treating liver cancer. The study aims to find safe and effective dose ranges for a combination of three drugs: sorafenib, sonidegib, and irinotecan.

Patient Parameters

Program Overview

The purpose of this study is to see if a new combination of three drugs—sorafenib, sonidegib, and irinotecan—can be safely given to patients with liver cancer and lead to better outcomes compared to standard treatments. The study will use artificial intelligence to help decide the best doses for each patient, aiming to make the treatment more effective while reducing side effects. Researchers will measure how well the drugs work by checking for cancer DNA in the blood and will monitor any side effects by looking at organ health and how well patients tolerate the treatment. The results will help determine the best doses for future studies.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older.
  • Diagnosed with advanced liver cancer confirmed by biopsy or specific imaging tests.
  • Not eligible for surgery or other local treatments aimed at curing the cancer, or the cancer has progressed after such treatments.
  • No more than one other active cancer at the time of joining the study.
  • Good overall health with an ECOG performance status of 2 or less.
  • Liver function classified as Child-Pugh class A or B7.
  • Expected to live for at least 12 more weeks.
  • At least one measurable tumor.
  • Specific lab test results, including:
    • Platelet count of 60,000 or more.
    • Hemoglobin level of 8.0 g/dL or more.
    • INR of 2.5 or less.
    • Albumin level of 2.5 g/dL or more.
    • Total bilirubin of 5 mg/dL or less.
    • ALT and AST levels 5 times the normal limit or less.
    • Creatinine level 2 times the normal limit or less.
  • Willing to provide written consent and follow study procedures.
  • Women and men with partners who can become pregnant must use effective birth control during the study and for a specified time after the last dose.

Exclusion Criteria

  • Women who can become pregnant and are not willing to use birth control during the study and for 20 months after the last dose.
  • Pregnant or breastfeeding women.
  • Any other health condition that could interfere with the study or increase the risk of complications, as judged by the doctor.
  • Prisoners or those involuntarily detained.
  • Unable to attend follow-up visits for up to 12 weeks after joining the study.
  • Planning major surgery during the study period.
  • Specific genetic condition (homozygosity for UGT1A1*28).

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.